Medical device for capturing stone fragments

ABSTRACT

A medical device for capturing one or more stone fragments includes a sheath having a proximal end and a distal end, a handle at the proximal end of the sheath, and a basket operable with the handle. The basket includes a plurality of wires that capture the stone fragments and has a collapsed configuration when the basket is positioned within the sheath and an expanded configuration when the basket is positioned beyond the distal end of the sheath. The medical device further includes an indicator that communicates to an operator of the medical device that the size of the stone fragments exceeds a predetermined limit and a release mechanism that releases the stone fragments from the plurality of wires when the size of the stone fragments exceeds the predetermined limit. The plurality of wires are able to reset into an operable position after releasing the stone fragments.

RELATED APPLICATION

This application is a continuation application of co-pending U.S. patentapplication Ser. No. 14/638,639, filed on Mar. 4, 2015, which is herebyincorporated by reference in its entirety.

FIELD

The present disclosure relates to a medical device. More specifically,the present disclosure relates to a medical device for capturing one ormore stone fragments.

BACKGROUND

The statements in this section merely provide background informationrelated to the present disclosure and may or may not constitute priorart.

During ureteroscopy or percutaneous nephrolithotomy (PCNL) procedures,baskets are often employed to capture and retrieve stone fragments froma patient's anatomy. After the stone fragments have been removed fromthe patient and released from the basket, the basket is re-inserted oneor more times into the patient's anatomy to remove all or most of theremaining stone fragments. In some instances, however, stone fragmentsthat are too large are captured in the basket, which may result in thebasket getting stuck in the ureter or access sheath. If the basket canbe pushed back, some fragments can be released and the basket can thenbe pulled out of the patient. If the basket is completely stuck, thebasket can be cut apart from the basket handle and sheath, or a smalllaser fiber may be inserted into the patient so that laser ablation canbe utilized to break up the stone fragments. In any case, if the basketdamaged, a new basket has to be employed to complete the medicalprocedure, which may increase the surgical time and costs.

Among the literature that can pertain to this technology include thefollowing patent documents and published patent applications: U.S. Pat.Nos. 7,645,283, 8,105,334, 7,678,119, US 2005/0261705, US 2010/0286709,DE3913936, EP1164945, and EP991361, the entire contents of which areincorporated herein by reference for all purposes.

Accordingly, to reduce surgical cost and time, there is a need for abasket that can size stone fragments during their retrieval to preventthe basket from getting stuck in the ureter or access sheath.

SUMMARY

The present invention provides an improved medical device for capturingone or more stone fragments and a method of using such a device.

In one aspect, a medical device for capturing one or more stonefragments includes a sheath having a proximal end and a distal end, ahandle at the proximal end of the sheath, and a basket operable with thehandle. The basket includes a plurality of wires that capture the stonefragments and has a collapsed configuration when the basket ispositioned within the sheath and an expanded configuration when thebasket is positioned beyond the distal end of the sheath. The medicaldevice further includes an indicator that communicates to an operator ofthe medical device that the size of the stone fragments exceeds apredetermined limit and a release mechanism that releases the stonefragments from the plurality of wires when the size of the stonefragments exceeds the predetermined limit. The plurality of wires areable to reset into an operable position after releasing the stonefragments.

The medical device may be further characterized by one or anycombination of the features described herein, such as, for example: theindicator is a visual indicator on a distal end of the plurality ofwires; the visual indicator is a color difference that is seen by theoperator of the device when the size of the stone fragments exceeds thepredetermined limit; the visual indicator is one or more laser marksthat is seen by the operator of the device when the size of the stonefragments exceeds the predetermined limit; the handle includes a movableportion and a fixed portion, the position of the movable portionrelative to the fixed portion being the indicator; the indicator is anexpandable cone positioned at the distal end of the sheath, theexpandable cone being configured to expand as the stone fragments arepulled into the cone with the basket, the expandable cone having amaximum diameter that indicates to the operator that the size of thestone fragments exceeds the predetermined limit; the indicator is anexpandable braided sleeve that is configured to be pushed over the stonefragments captured by the basket, the sleeve having a maximum diameterthat indicates to the operator that the size of the stone fragmentsexceeds the predetermined limit; the release mechanism includes a firstportion of the plurality of wires and a second portion of the pluralityof wires that is rotatable relative to the first portion of theplurality of wires about a longitudinal axis of the sheath, the secondportion of the plurality of wires being rotated relative to the firstportion of the plurality of wires when the size of the stone fragmentsexceeds the predetermined limit; the plurality of wires are a pluralityof non-woven pre-shaped petals, the plurality of non-woven pre-shapedpetals operating as the release mechanism when they expand and releasethe stone fragments when the size of the stone fragments exceeds thepredetermined limit; the plurality of wires are made of shape-memoryalloy and the petals are pre-shaped to the closed configuration of thebasket; each petal has engagement hooks, the hooks of adjacent petalsbeing engaged when the stone fragments are captured by the basket andthe hooks of adjacent petals being unengaged to release the stonefragments when the size of the stone fragments exceeds the predeterminedlimit; and the basket has a deployed basket configuration with a distalopening sized to limit an acquirable stone fragment size.

In another aspect, the present disclosure provides a method of sizingone or more stone fragments including one or more of the followingsteps: at least partially surrounding a stone with a stone capturedevice; utilizing an indicator to determine if the size of the stonefragments exceeds a predetermined limit; and releasing the stonefragments if the size of the stone fragments exceeds the predeterminedlimit. The method may be further characterized by one or any combinationof the features described herein, such as, for example: the indicator isa visual indicator; and the indicator is a tactile indicator.

Further features, advantages, and areas of applicability will becomeapparent from the description provided herein. It should be understoodthat the description and specific examples are intended for purposes ofillustration only and are not intended to limit the scope of the presentdisclosure.

DRAWINGS

The drawings described herein are for illustration purposes only and arenot intended to limit the scope of the present disclosure in any way.The components in the figures are not necessarily to scale, emphasisinstead being placed upon illustrating the principles of the invention.Moreover, in the figures, like reference numerals designatecorresponding parts throughout the views. In the drawings:

FIG. 1A is a schematic view of a device for capturing stone fragments inaccordance with the principles of the present invention;

FIG. 1B is a partial cross-sectional view of the device shown in FIG.1A;

FIGS. 2A-2C are schematic views of another device for capturing stonefragments in accordance with the principles of the present invention;

FIGS. 3A-3C are schematic views of yet another device for capturingstone fragments in accordance with the principles of the presentinvention;

FIG. 4A is a schematic view of yet another device for capturing stonefragments in accordance with the principles of the present invention;

FIG. 4B is a partial expanded view of the device shown in FIG. 4A;

FIG. 5A is a schematic view of yet another device for capturing stonefragments in accordance with the principles of the present invention;

FIG. 5B is a partial expanded view of a basket for the device shown inFIG. 5A;

FIG. 5C is a schematic view of engaged petals of the basket shown inFIG. 5A;

FIG. 6A is a schematic view of yet another device for capturing stonefragments when in an open configuration in accordance with theprinciples of the present invention;

FIG. 6B is a schematic view of the device shown in FIG. 6A in a closedconfiguration;

FIGS. 7A and 7B are schematic views of another device for capturingstone fragments in accordance with the principles of the presentinvention; and

FIGS. 8A-8C are schematic views of a handle portion of yet anotherdevice for capturing stone fragments in accordance with the principlesof the present invention.

DETAILED DESCRIPTION

The following description is merely exemplary in nature and is notintended to limit the present disclosure, application, or uses.

Referring now to the drawings, a medical device for capturing one ormore stone fragments is illustrated in FIGS. 1A and 1B and designated at10. The capturing device 10 includes an outer sheath 12 with a distalend 11 and a proximal end 13. An expandable cone 14 is attached to thedistal end 11 of the sheath 12. In certain arrangements, the cone 14includes a plurality of pleats 14 which enable the cone 14 to expand asone or more stone fragments 30 are pulled into the cone 14.

The capturing device 10 further includes a capturing basket 16positioned within the sheath 12 and expandable cone 14. The capturingbasket 16 includes a rod or handle 24 with a distal end 26 and aproximal end 28. A pair of wires 18 and 20 are attached to the distalend 26 of the handle 24. Specifically, the ends of each of the wires 18and 20 are attached to the distal end 26 such that the mid region of thewires 18 and 20 intersect at the distal most end of the capturing basket16. As shown in FIGS. 1A and 1B, the wires 18 and 20 are generallyorthogonal to each other at the distal point of intersection.

When the capturing device 10 is in use, the capturing basket 16 isinitially collapsed within the cone 14. After, the wires 18 and 20 andcone 14 have been positioned in an anatomical region of a patientcontaining stone fragments, a user of the capturing device 10, such as,for example, a physician, pushes on the proximal end 28 of the handle 24such that the wires 18 and 20 exit a distal end 22 of the expandablecone 14. After the stone fragments 30 have been captured by the wires 18and 20, the physician pulls on the proximal end 28 to draw the stonefragments 30 into the cone 14, which causes the cone 14 to expand. Thedistal end 22 of the cone 14 is configured to expand to a maximumpredetermined size. If the size of the captured stone fragments 30exceeds this limit, the physician is unable to pull the stone fragmentsfurther into the cone 14. The physician then pushes the proximal end 28,which results in the wires 18 and 20 to move away from the cone 14 sothat some of the stone fragments can be released. If initially or insubsequent attempts, the size of the stone fragments 30 does not exceedthe predetermined size limit of the cone 14, the physician proceeds withretrieving the stone fragments from the patient's anatomy.

Referring now to FIGS. 2A, 2B and 2C, there is shown a capturing device100. The capturing device 100 includes the aforementioned capturingbasket 16 positioned within a sheath 112 that has a proximal end 113 anda distal end 115. The capturing device 100 further includes a braidedsleeve or mesh 114 that slides over the sheath 112 and the capturingbasket 16.

When the capturing device 100 is in use, the wires 18 and 20 areinitially collapsed within the sheath 112, and the mesh 114 is slid overthe sheath 112. A user, such as, for example, a physician, of thecapturing device 100 then pushes on the proximal end 28 of the handle 24such that the wires 18 and 20 are pushed out of the distal end 115 ofthe sheath 112 to an expanded configuration as shown in FIG. 2B. Afterone or more stone fragments 20 are captured with the capturing device16, the physician pulls on the proximal end 28 of the handle 24.Consequently, the stone fragments 30 are pulled into a distal end 122 ofthe mesh 114, which causes the distal end 122 to expand into aconeshaped configuration 117 (FIG. 2C). If the accumulation of stonefragments 30 can be pulled through the mesh, then the physiciancontinues to pull on the proximal end 28 of the rod 24 to retrieve thestone fragments 30 from the patient's anatomy. If the distal end 122 ofthe mesh 114 expands to a maximum limit and the size of the stonefragments exceeds this limit, the physician then pushes on the proximalend 28 of the handle 24 to release some of the stone fragments 30 sothat the size of the stone fragments 30 is reduced to a size that allowsthe stone fragments to be pulled through the mesh 114.

Turning now to FIGS. 3A and 3B, there is shown yet another capturingdevice 200. The capturing device 200 includes a pair of rods 230 and 232located within a sheath 212 that has a proximal end 211 and a distal end215. The capturing device 200 further includes a capturing basket 216attached to the distal ends 226 and 228 of the rods 230 and 232,respectively. Specifically, the ends of the wire 218 are attached to thedistal end 228 of the rod 232, and the ends of the wire 220 are attachedto the distal end 226 of the rod 230. The rod 232 is configured torotate relative to the rod 230 as indicated by the double arrow 240 byturning, for example, a knob 213 connected to the rod 232 and positionedproximally to the proximal end 211 of the sheath 212.

When the capturing device 200 is in use, the wires 218 and 220 areinitially collapsed within the sheath 212. The physician then pushes onthe knob 213 such that the wires 218 and 220 emerge from the distal end215 of the sheath 212, resulting in the wires 218 and 220 opening up toan expanded configuration. The physician then turns the knob 213 torotate the rod 232. Hence, the wire 218 attached to the rod 232 rotatesrelative to the wire 220 that is attached to the rod 230. Accordingly,the physician can rotate the wire 218 such the wire 218 is orthogonal tothe wire 220 in a capture configuration (FIG. 3B) to capture stonefragments, or the wire 218 can be rotated relative to the wire 220 to arelease configuration (FIG. 3C) to allow stone fragments to be releasedfrom the capture basket 216. Note that when the basket 216 is in thecapture configuration, the wires 218 and 220 are oriented orthogonal toeach other and define an interior region with a maximum predeterminedsize limit. Hence, stone fragments with a size that does not exceed thispredetermined size limit can be retrieved with the capturing device 200.

Referring now to FIGS. 4A and 4B, there is shown a capturing device 300with a rod or handle 312 and a basket 314 attached to a distal end 315of the handle 312. The basket includes a plurality of petals such as,for example, a set of four non-woven petals 316, 318, 320 and 322. Thepetals 316, 318, 320 and 322 operate as a release mechanism when theyexpand and release stone fragments when the size of the accumulatedstone fragments exceeds a predetermined size limit. In a particulararrangement, the petals 316, 318, 320 and 322 are made of a shape-memoryalloy, such as, for example, Nitinol. The petals 316, 318, 320 and 322may be pre-shaped to a closed configuration, such that the petals 316,318, 320 and 322 collapse back to the closed configuration afterreleasing stone fragments.

Referring to FIGS. 5A, 5B and 5C, there is shown a capturing device 400,which is a modification of the capturing device 300. The capturingdevice 400 includes a rod or handle 412 and a basket 414 attached to adistal end 415 of the handle 412. The basket 414 includes a plurality ofpetals such as a set of four petals 416, 418, 420 and 422.

The sides of each petal 416, 418, 420 and 422 are configured to engage aside of an adjacent petal. More particularly, the sides of the petalshave engagement hooks 416A, 416A′, 418A, 418A′, 420A, 420A′, 422A and422A′ that are configured to engage with an adjacent engagement hook.For example, as shown in FIG. 5C, the engagement hook 416A′ is engagedwith the engagement hook 418A, the engagement hook 418A′ is engaged withthe engagement hook 420A, and the engagement hook 420A′ is engaged withthe engagement hook 422A. The engagement hook 422A′ is engaged with theengagement hook 416A to complete the basket structure. Hence, when thecapturing device 400 is in use, the hooks 416A, 416A′, 418A, 418A′,420A, 420A′, 422A and 422A′ of adjacent petals are engaged when thestone fragments are captured by the basket 414. The hooks 416A, 416A′,418A, 418A′, 420A, 420 k, 422A and 422A′ become unengaged to release thestone fragments when the size of the stone fragments exceeds apredetermined size limit. In a particular arrangement, the petals 416,418, 420 and 422 are made of a shape-memory alloy, such as, for example,Nitinol. The petals 416, 418, 420 and 422 may be pre-shaped to a closedconfiguration, such that the petals 416, 418, 420 and 422 collapse backto the closed configuration after releasing stone fragments.

Referring now to FIGS. 6A and 6B, there is shown yet another capturingdevice 500. The capturing device 500 includes a handle or rod 512 and abasket 514 attached to a distal end 515 of the handle 512. The basket514 includes a plurality of legs such as, for example, a set of fourlegs 516 shown in FIG. 6A. Each leg 516 has two different markings 518and 520. The markings 518 and 520 may be two different colors or twodifferent patterns formed on the legs, for example, by laser etching.(Note that such differentiated markings can be used in conjunction withthe petals associated with the capturing devices 300 and 400 describedpreviously.)

Accordingly, when the capturing device 500 is in use, the physician isable to view the basket 514 down the length of the handle 512. Hence,when the stone fragments are captured in the basket 514 in a closedconfiguration (FIG. 6B) or a partially closed configuration, themarkings 518 will take up a smaller field of view or some of themarkings will be drawn inside the basket sheath 512 and no longer bevisible versus when the basket 514 is in a more expanded configuration(FIG. 6A) where the markers take up a larger field of view or more ofthe markers are visible, which occurs when the size of the capturedstone fragments exceed a predetermined size limit.

Referring to FIGS. 7A and 7B, there is shown a capturing device 600 thatillustrates another type of visual indicator that provides informationto the physician when the size of the stone fragments exceed apredetermined size limit. The capturing device 600 includes a mesh orbasket 610 and an indicator 612 attached to a distal end 613 of thebasket 610. The indicator 612 includes a generally curved and partiallyhollow portion 614 and a curved solid wire or rod 616. The wire 616includes an end portion 618 attached to the curved portion 614 andanother end portion with markings 620. The wire 616 is able to slidewithin the hollow interior region of the portion 614. Hence, if thephysician cannot see the markings 620 (FIG. 7A) during the capture andretrieval of stone fragments, then the stone fragments captured by thebasket 612 do not exceed a predetermined limit. If, however, themarkings 620 extend beyond the end 622 of the portion 614 so that themarkings 620 are visible to the physician, then the size of the stonefragments exceed the predetermined size limit. In some arrangements ofthe capturing device 600, the markings 620 are a different color thanthe rest of the wire 616 and the portion 614. In other arrangements, themarkings 620 are formed by laser etching.

Turning now to FIGS. 8A, 8B and 8C, there is shown a handle portion of acapturing device 700. The handle 700 includes a fixed portion 712 and amovable portion 714 that moves or slides relative to the fixed portion712. In various arrangements, any one of the aforementioned basketconfigurations can be fully or partially positioned within the fixedportion 712 and connected to the movable portion 714. Accordingly, asthe movable portion 714 is slid or moved upwards (as viewed in the planeof the page) relative to the fixed portion 712, the basket expands to anopen configuration, and, as the movable portion 714 is slid downward,the basket closes to a closed configuration, for example, to capturestone fragments. If the physician pulls on the pulls on the movableportion 714 in the direction of the arrow 720 but an end 718 of themovable portion 714 cannot be moved past a visual indicator 716 (FIG.8B), then the size of the captured stone fragments exceeds apredetermined size limit. On the other hand, if the end 718 lines upwith (FIG. 8C) or moves past the indicator 716 in the direction of thearrow 720, then the size of the stone fragments does not exceed thepredetermined size limit.

The description of the invention is merely exemplary in nature andvariations that do not depart from the gist of the invention areintended to be within the scope of the invention. Such variations arenot to be regarded as a departure from the spirit and scope of theinvention.

1-15. (canceled)
 16. A medical device configured to capture one or morestone fragments, the medical device comprising: a sheath having aproximal end and a distal end; a basket movably connected to the sheath,where the basket comprises a collapsed configuration when the basket ispositioned within the sheath and where the basket comprises a closedexpanded configuration when the basket is positioned beyond the distalend of the sheath, where the basket comprises a plurality of wires whichare configured to capture the one or more stone fragments; and anindicator configured to communicate to an operator of the medical devicethat a size of the one or more stone fragments captured with theplurality of wires exceeds a predetermined limit, where the indicatorcomprises at least one visual indicator located proximate the basket.17. The medical device as in claim 16 where the at least one visualindicator is located on the basket.
 18. The medical device as in claim16 where the plurality of wires are configured to reset into the closedexpanded configuration after releasing the one or more stone fragments.19. The medical device as in claim 16 further comprising a releasemechanism which is configured to release the one or more stone fragmentsfrom the plurality of wires when the size of the one or more stonefragments exceeds the predetermined limit.
 20. The medical device as inclaim 19 where the release mechanism comprises a first portion of theplurality of wires and a second portion of the plurality of wires, wherethe second portion of the plurality of wires is rotatable relative tothe first portion of the plurality of wires about a longitudinal axis ofthe sheath, where the second portion of the plurality of wires areconfigured to be rotated relative to the first portion of the pluralityof wires when the size of the stone fragments exceeds the predeterminedlimit.
 21. The medical device as in claim 19 where the plurality ofwires comprise a plurality of non-woven pre-shaped petals, where theplurality of non-woven pre-shaped petals are configured to operate asthe release mechanism when the plurality of non-woven pre-shaped petalsexpand and release the one or more stone fragments when the size of theone or more stone fragments exceeds the predetermined limit.
 22. Themedical device as in claim 16 where the at least one visual indicator islocated on distal ends of the plurality of wires.
 23. The medical deviceas in claim 16 where the at least one visual indicator comprises a colordifference configured to be seen by the operator of the medical devicewhen the size of the one or more stone fragments exceeds thepredetermined limit.
 24. The medical device as in claim 16 where the atleast one visual indicator comprises one or more laser marks that isconfigured to be seen by the operator of the medical device when thesize of the stone fragments exceeds the predetermined limit.
 25. Themedical device as in claim 16 further comprising a handle, where thehandle comprises a movable portion and a fixed portion, where theindicator comprises a position of the movable portion relative to thefixed portion being configured to provide an indication to the operatorof the medical device.
 26. The medical device as in claim 16 where theindicator comprises an expandable cone positioned at the distal end ofthe sheath, where the expandable cone is configured to expand as the oneor more stone fragments are pulled into the cone with the basket, wherethe expandable cone comprises a maximum diameter which is configured toindicate to the operator of the medical device that the size of the oneor more stone fragments exceeds the predetermined limit.
 27. The medicaldevice as in claim 16 where the indicator comprises an expandablebraided sleeve that is configured to be pushed over the one or morestone fragments captured with the basket, where the sleeve comprises amaximum diameter which is configured to indicate to the operator of themedical device that the size of the one or more stone fragments exceedsthe predetermined limit.
 28. The medical device as in claim 27 where thepetals comprise engagement hooks, where the engagement hooks of adjacentpetals are configured to engage when the one or more stone fragments arecaptured by the basket and the engagement hooks of the adjacent petalsare configured to unengaged to release the one or more stone fragmentswhen the size of the one or more stone fragments exceeds thepredetermined limit.
 29. The medical device as in claim 16 where theindicator comprises an expandable sleeve that is configured to bedisposable over the basket.
 30. The medical device as in claim 16 wherethe plurality of wires form a first set of petals having a firstconfiguration and a second set of petals having a second configurationdifferent from the first configuration, where the first and second setof petals are configured to expand to another expanded configurationwhich is larger than the closed expanded configuration to release thestone fragments when a size of the one or more stone fragments exceeds apredetermined limit, wherein the plurality of wires are configured toreset from the another expanded configuration into the closed expandedconfiguration after releasing the one or more stone fragments.
 31. Themedical device as in claim 16 where the distal end of the sheathcomprises an expandable cone, where the expandable cone is configured toexpand as the one or more stone fragments are pulled into the expandablecone with the basket.
 32. The medical device as in claim 31 where theexpandable cone comprises at least one upper limit diameter which isconfigured to indicate to the operator of the medical device, as atleast part of the indicator, that the size of the one or more stonefragments exceeds the predetermined limit.
 33. The medical device as inclaim 16 where the distal end of the sheath comprises an expandablebraided sleeve that is configured to be pushed over the one or morestone fragments captured with the basket.
 34. The medical device as inclaim 33 where the expandable braided sleeve comprises at least oneupper limit diameter which is configured to indicate to the operator ofthe medical device, as at least part of the indicator, that the size ofthe one or more stone fragments exceeds the predetermined limit.
 35. Amedical device configured to capture one or more stone fragments, themedical device comprising: a sheath having a proximal end and a distalend; a handle at the proximal end of the sheath; a basket operable withthe handle, the basket having a collapsed configuration when the basketis positioned within the sheath and having a closed expandedconfiguration when the basket is positioned beyond the distal end of thesheath, the basket including a plurality of wires that are configured tocapture the one or more stone fragments; an indicator which isconfigured to communicate to an operator of the medical device that asize of the one or more stone fragments exceeds a predetermined limit,where the indicator comprises a visual indicator located on the basket;and a release mechanism which is configured to release the one or morestone fragments from the plurality of wires when the size of the one ormore stone fragments exceeds the predetermined limit, where theplurality of wires are configured to reset into an operable positionafter releasing the one or more stone fragments.